AccessGUDID - DEVICE: PTS Connect™ Universal Solution (00381933771015)

GUDID

Device Identifier (DI) Information

Brand Name: PTS Connect™ Universal Solution
Version or Model: 3771
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3771
Company Name: POLYMER TECHNOLOGY SYSTEMS, INC.

Primary DI Number: 00381933771015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 835772872 *Terms of Use

Device Description: The PTS Connect™ Universal Solution offers the ability to connect wired and wireless PTS Diagnostics analyzers to the PTS Connect Universal Solution. The PTS Connect Universal Solution will collect test results from the connected devices, generate patient results, and allow the user to export data.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35477	Clinical laboratory information system	A dedicated assembly of devices designed to electronically receive, collect, store, display, output and distribute clinical laboratory information (e.g., transfer of digital images), within or between healthcare facilities, to support the administrative and clinical activities associated with clinical laboratory services and facilities. Some systems will also assist in data management/analysis. The system consists of dedicated combined hardware (e.g., computers, terminals, network components) and software (typically embedded, and not directly used to run, steer, or control laboratory analysers or equipment).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OUG	Medical device data system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 450e9828-6bd0-4b2b-bda7-2de237c66de5
Public Version Date: April 14, 2022
Public Version Number: 3
DI Record Publish Date: July 15, 2016